The Journal of GXP Compliance
Vol. 25, Issue 3, May 2021

Jeanne Moldenhauer
,
Paul L. Pluta
,
Stacey L. Bruzzese
The idea for Audit Forum came from multiple sources. Validation and Quality Managers have often requested that audits topics be addressed in the IVT journals; there is universal agreement among industry personnel for the need to address topics related to audits. Regulatory agencies have been forefront in audit practice changes.
Tim Sandle
No mask is 100% effective. Masks are a tradeoff between bacterial and particle efficiency and user comfort, with a 97.5% bacterial filter efficiency the typical rating. Achieving this is dependent upon the mask integrity and worn correctly. This paper covers cleanroom contamination control, more recent research within the medical field has been...
Paul L. Pluta
Medication errors occur in writing, print, speaking, and electronic communications; all of these modes must be considered in development of the drug name. The perspectives of health professionals with product name usage on a daily basis is far different than that of industry personnel who develop drug names for product recognition and commercial...
Jeremy M. Ebersole
Statistics Roundtable is a new IVT feature that will provide readers an opportunity to discuss information about statistics and demonstrate the application of statistics to pharmaceutical problems. The use of statistics is fundamental in regulated industries. The statistical basis for decision-making is an expectation. Any effort to increase the...
Tim Sandle
Temperature and humidity control are important factors to control within the cleanroom. For pharmaceuticals and healthcare products, this relates to three areas. The first is to avoid extremes affecting the skin of the operator, and hence the ability of the cleanroom gown to contain contamination...
Richard C. Wedlich
,
Ulyana Matyugicheva
The Chemical Hygiene Officer must play an active role and have a strong presence in the lab, providing feedback and expertise and keeping lines of communication open between lab workers and management. The efficient facility run with good administration reflects a superior understanding of division of labor and conflict of interest. Although the...
Jeanne Moldenhauer
Since the beginning of the Covid-19 pandemic, business life has changed. There is a reluctance to travel. Companies are reluctant to have visitors on site. There has been a significant increase in employees working from home have also been increases in having meetings held virtually. This has resulted in a significant reduction in company audits...
Stacey L. Bruzzese
On behalf of the IVT Network staff and Editorial Advisory Board, a sincere congratulations to Roberta Goode on her upcoming induction to the Florida Inventors Hall of Fame. Roberta is one of seven Florida Inventors whose discoveries are saving lives, transforming the environment, and creating new technologies, and she will be inducted as part of...
Stacey L. Bruzzese
Updates to guidances on clinical trial development were recently published by the ICH Management Committee in a draft format. This updated document reveals principles that are currently under development by the ICH E6 (R3) Expert Working Group.
Christopher Flask
As vaccines roll out more broadly, and countries begin to get the coronavirus under control, attention will turn to the recovery and a return to normal operations. The supply chain will play an integral role in this effort, and will itself emerge in a different shape, with transportation, warehousing and API sourcing looking much different than it...
Chris Wubbolt
Following a year of remote working we have all become accustomed to virtual business days. Post-pandemic, many businesses may continue to use remote or hybrid models of working for employees where possible, including the pharmaceutical and device industries. Understanding the unique data integrity and validation oversight needed in virtual...
Lorianne Richter
,
Nuala Calnan
,
Rob De La Espriella
Lori and Nuala, have broken ranks and jumped sectors to the Commercial Nuclear Industry to invite their guest Rob De La Espriella to share his insights and expertise on the need for critical thinking and complex problem solving skills in getting to the root of the matter when we investigate, correct and prevent failures.
Ivan Soto
Although most companies in the industry have Business Continuity Plans, most of them were not detailed or inclusive enough to provide contingencies for all impacted functional areas. In this discussion we will highlight strategies that enable validation leaders and teams to keep validation activities functional and productive not only throughout...
Vladimir Gostuski
Ventilators recently discovered in a Miami Landfill may have been discarded due to the maker's omission, FDA's list of ventilators under Emergency Use Authorization (EUA) for the COVID-19 pandemic. In this post the author provides notes on the FDA's current guidelines around import of ventilators and the commercial use...
Emilia N. Faraj
As more users are taking control of their own health, increasingly wearable devices have become popular amongst all ages. With different brands and names in the market, their use varies and has tripled in the last few years. These devices not only collect exercise variables like steps walked or calories burned but have now increased their use to...
Coralin Nogues
The FDA and CDC released a joint statement lifting the recommended pause on the J&J- Janssen COVID-19 Vaccine. but this move may have been to late to maintain public trust when it comes to the effectiveness and safety. While this temporary suspension was recommended out of an abundance of caution, less than 1 in 4 unvaccinated Americans are...
Validation Week 2021

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